The objective of this registry is to gain more insight on the clinical use of the Occlutech perimembranous VSD occluder.
Study Type
OBSERVATIONAL
Enrollment
50
Children Health Ireland
Dublin, Ireland
Queen Sirikit National Institute of Child Health
Bangkok, Thailand
Prince of Songkla University
Hat Yai, Thailand
Osmangazi University Faculty of Medicine Hospital
Eskişehir, Turkey (Türkiye)
To confirm the efficacy of Occlutech PmVSD in patients requiring transcatheter occlusion (closure) of perimembranous ventricular septal defects.
The primary efficacy endpoint is defined as successful implantation of the device with a proper closure of the pmVSD (defined as reduction in VSD shunt of more than one grade as assessed by TTE post implantation).
Time frame: 1 year following implantation
To confirm the safety of Occlutech PmVSD in patients requiring transcatheter occlusion (closure) of perimembranous ventricular septal defects.
The primary safety endpoint is defined as absence of Serious Adverse Device Effects (SADEs) including procedure-related death, procedure-related stroke, systemic embolism, severe hemolysis, complete heart block requiring pacemaker implantation or device explantation, new-onset of severe tricuspid regurgitation (TR), new onset of severe aortic regurgitation (AR), device embolization, severe right-left ventricular outflow obstruction (RVOTO-LVOTO), cardiac tamponade, infective endocarditis or vascular complications requiring surgery.
Time frame: 1 year following implantation
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Gaziantep University Hospital
Gaziantep, Turkey (Türkiye)
Izmir University of Health Sciences Tepecik Training and Research Hospital
Izmir, Turkey (Türkiye)
Kocaeli University Research and Application Hospital
Kocaeli, Turkey (Türkiye)
City Children Hospital
Ho Chi Minh City, Vietnam